Operator Manual Rotolavit II and Rotolavit II-S en Rev2.5

Operating Instructions
Cell Washer Centrifuge Hettich Rotolavit II and Rotolavit II-S
Hettich AG, Seestrasse 204a, 8806 Baech, Switzerland Operator_Manual_Rotolavit II_und_Rotolavit II-S_en_rev2.5
1
manufactured by
Hettich AG
Seestrasse 204a
CH-8806 Baech / Switzerland
phone +41 (0)44 786 80 20

info@hettich.ch
www.hettich.ch
© 2020 by Hettich AG
All rights reserved. No part of this publication may be reproduced without the prior written permission of the
copyright owner.
Modifications reserved!
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EG-KONFORMITÄTSERKLÄRUNG / EC-DECLARATION OF CONFORMITY
DECLARATION DE CONFORMITE CE/ DICHIARAZIONE DI CONFORMITA CE
DECLARACIÓN DE CONFORMIDAD CE / DECLARAÇÃO DE CONFORMIDADE CE
Name und Adresse des Herstellers Hettich AG, Seestrasse 204a,

Name and address of the manufacturer CH-8806 Baech, Switzerland
Nom et adresse du fabricant Tel. +41 44 786 80 20, Fax. +41 44 786 80 21
Nome e indirizzo del produttore info@hettich.ch
Nombre y dirección del fabricante
Nome e endereço do fabricante
Wir erklären in alleiniger Verantwortung, dass das Medizinprodukt für die In-vitro-Diagnostik
We declare, with sole responsibility, that the medical product for in-vitro diagnostics
Nous déclarons, sous notre seule responsabilité, que le produit médical pour le diagnostic in-vitro
Dichiariamo sotto la nostra unica responsabilità che il dispositivo medico-diagnostico in vitro
Declaramos bajo nuestra exclusiva responsabilidad que el dispositivo médico es para uso diagnóstico in vitro
Declaramos, sob a nossa inteira responsabilidade, que o dispositivo médico para diagnósticos in vitro
Rotolavit II, Rotolavit II-S

und / and / et / e / y / e
UltraCW II
ab Seriennummer / from serial-number / dès le numéro de série / a partire dal numero di serie /
desde el número de serie / a partir do número de série
0000030
gefertigt in der Schweiz / manufactured in Switzerland / fabriqué en Suisse / prodotto in Svizzera /

fabricado en Suiza / fabricado na Suíça
mit folgender Klassifizierung nach der Richtlinie über In-vitro-Diagnostika 98/79/EG, Anhang III
classified as follows according to the directive on in vitro diagnostic medical devices 98/79/EC, annex III
avec la classification selon la directive relative aux dispositifs médicaux de diagnostic in vitro 98/79/CE, appendice III
con la classificazione secondo la direttiva relativa ai dispositivi medico-diagnostici in vitro 98/79/CE, appendice III
con la siguiente clasificación según la directiva sobre dispositivos médicos de diagnóstico in vitro 98/79/CE, anexo III
com a seguinte classificação segundo a diretiva relativa aos dispositivos médicos de diagnóstico in vitro 98/79/CE, anexo III
X Sonstiges Produkt / Other device / Autre dispositif / Altro dispositivo / Otro producto / Outro produto
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allen Forderungen der Richtlinie über In-vitro-Diagnostika 98/79/EG, Anhang III entspricht, die anwendbar sind.
meets all the provisions of the directive on in vitro diagnostic medical devices 98/79/EC, annex III which apply to it.
remplit toutes les exigences de la directive relative aux dispositifs médicaux de diagnostic in vitro 98/79, appendice III CE qui
le concernent.
soddisfa tutte le disposizioni della direttiva relativa ai dispositivi medico-diagnostici in vitro 98/79/CE, appendice III che lo
riguardano.
cumplir con todos los requisitos de la directiva sovre dispositivos médicos de diagnóstico in vitro 98/79/CE, anexo III que
sean aplicables.
está em conformidade com todos os requisitos da diretiva relativa aos dispositivos médicos de diagnóstico in vitro
98/79/CE, anexo III aplicáveis.
Angewandte gemeinsame technischen Spezifikationen, harmonisierte EN 61010-1

Normen, nationale Normen oder andere normative Dokumente EN 61010-2-020
Applied common technical specifications, harmonised standards, national EN 61326-1
standards or other normative documents RoHS II Directive 2011/65/EU
Spécifications techniques communes, normes harmonisées, normes WEEE Directive 2002/96/EU
nationales et autres documents normatifs appliqués
Specifiche tecniche comuni, norme Armonizzate o nazionali applicate,
altri Documenti normativi applicati
Especificaciones técnicas comunes aplicadas, normas armonizadas,
normas nacionales o otros documentos normativos
Especificaciones técnicas comunes aplicadas, normas armonizadas,
normas nacionales o otros documentos normativos
Especificações técnicas comuns aplicadas, normas harmonizadas,

normas nacionais ou outros documentos normativos
Baech, 30. September 2019 Doris Friedlos Geschäftsleiterin / CEO /

Directrice général / Gerente
Ort, Datum / Place, date / Name und Funktion / Name and function /
Lieu, date / Luogo, data / Lugar, fecha / Local, data Nom et fonction / Nome e funzione / Nombre y función /
Nome e função
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Contents
1 Used terms and signs 8
1.1 Explanation of the terms 8
1.2 Explanation of signs 8
2 Use according to the specifications 9
2.1 Versions 9
2.2 Storage and forwarding the operator-manual 9
2.3 Responsibility of the owner 10
2.4 Requirements of the operating personnel 10
2.5 Changes and alterations 10
2.6 Warranty 11
3 Notes on safety 11
4 Behaviour in case of malfunctions and irregularities 13
4.1 Remaining risks 13
4.2 Switching off the device in an emergency 13
4.3 Emergency release 13
5 Technical specifications 14
6 Unpacking the centrifuge 15
6.1 Storage after delivery 15
6.2 Installation after storage 15
6.3 Delivery checklist 16
6.4 Disposing of packaging material 16
6.5 Transportation 16
7 Installing the wash centrifuge 17
7.1 Connections 17
7.2 Accessory 18
7.3 First steps 19
7.4 Starting the wash centrifuge 21
7.5 Install and remove the rotor 21
8 Operation settings 22
8.1 Overview 22
8.1.1 Password protection 23
8.2 Start screen 23
8.3 Select program 24
8.4 Add a new program 24
8.5 System settings 24
8.5.1 History 25
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8.5.2 Language, date and time settings 25
8.5.3 Edit password 25
8.6 Service menu 26
8.6.1 Calibration 26
8.6.2 User settings 27
8.6.3 Device settings 27
8.6.4 Network settings 28
9 Programs 28
9.1 Starting the program 28
9.2 Stop a running program 30
9.3 Pre-installed programs 31
9.3.1 flush 31
9.3.2 refill pump 31
9.3.3 wash redcells 3 5ml 3x (wash erythrocytes, 3.5 ml, 3 x) 32
9.3.4 agit and spin 32
9.3.5 decant 32
9.3.6 spin 20sec 3500rpm 32
9.3.7 susp 3 5ml spin 20sec (centrifuge 3.5ml suspension for 20sec) 32
9.3.8 wash 3 5ml 3x and anti (wash 3.5 ml, 3 x, plus antihuman globulin test) 33
9.3.9 wash white cells Tspot (wash leukocytes, Tspot) 33
9.3.10 cell recovery (only device type 1008-00S) 33
9.2.11 immunophenotyping (only device type 1008-00S) 33
9.4 Process descriptions 34
9.4.1 Principle 34
9.4.2 FILL 1 process 34
9.4.3 FILL 2 process 34
9.4.4 DOWN process 35
9.4.5 SPIN process 35
9.4.6 DECANT process 36
9.4.7 AGIT process 36
9.4.8 LOOP process 37
9.4.9 CHECK process 37
9.5 Add a new program 38
10 Adjusting 40
10.1 Entering the rotor type 40
10.2 Calibrating the filling volume 40
10.3 Audible signal 41
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10.4 Relative centrifugal force (RCF) 41
10.5 Querying operating hours 41
11 Centrifugation of materials or mixtures of materials with a density higher than 1.2 kg / dm3 42
12 Maintenance and servicing 42
12.1 Centrifuge 43
12.2 Rotor 44
12.3 Autoclaving 44
12.4 Removal of the splash guard receiver and cap 45
12.5 Flushing the system with deionized or distilled water 45
12.6 Cleaning the system with cleaning solution 45
12.7 Glas breakage 46
12.8 Repairs 46
12.9 Rotor crash 46
12.10 Maintenance schedule 47
13 Faults and errors 48
13.1 Operator faults 48
13.2 Software error codes 49
13.3 Changing the fuse 51
14 Returning the device / parts of it 51
15 Storage 51
15.1 Disposal 52
16 Appendix 53
16.1 Rotors and accessories 53
16.2 Spare parts 55
16.3 Document history 56
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1 Used terms and signs
In this manual and on the device, certain common terms and signs are used to warn you of possible dangers
or to give you hints that are important in avoiding injury or damage. Observe and follow these hints and
regulations to avoid accidents and damage. These terms and signs are explained below.
1.1 Explanation of the terms

Warning is used whenever you or somebody else could be injured if you do not observe the
accompanying safety regulation.
Caution is used for information that is important for avoiding damage.
1.2 Explanation of signs

Caution is used for information that is important for avoiding damage.
Symbol on the device:

Attention, general hazard area.
Before using the device, make sure you read the operating instructions and observe the safety
information!
Symbol in this document:

Attention, general hazard area.
This symbol refers to safety relevant warnings and indicates possibly dangerous situations.
The non-adherence to these warnings can lead to material damage and injury to personnel.

This symbol refers to important circumstances.
Symbol on the device and in this document:

Beware of biohazard.
Symbol on the device and in this document:

Symbol for the separate collection of electric and electronic devices according to the guideline
2002/96/EG (WEEE). The device belongs to Group 8 (medical devices).
Applies in the countries of the European Union, as well as in Norway and Switzerland.

Disconnect the mains plug

Wear protective gloves

Important or useful additional information
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2 Use according to the specifications
The present device is a wash centrifuge intended for in-vitro diagnostic applications, in accordance with
“Directive 98/79 EC”. The sample processing with the use of the device and the corresponding inserts is realised
by the filling with a washing liquid and subsequent shaking, centrifuging and decanting. The device itself is used
for sample processing and not for sample analysis.
The following device types are available for this device:
Rotolavit II, Type 1008-00 and 1008-03

These device types are used to wash respectively to clean erythrocytes for carrying out quick anti-human globulin
tests (direct and indirect Coombs tests) in crossmatch, antibody screening and differentiation.
Leukocytes can be washed in the same way to prepare samples for tuberculosis or tumour testing. The device
is intended exclusively for the applications mentioned and is only allowed to be used in closed clinical
laboratories by medically trained specialists.
Rotolavit II-S, Type 1008-00S
This device type is used to wash respectively to clean blood or other cell-containing samples to prepare the flow
cytometric analysis on a sample preparation system and flow cytometer. The process steps can be individually
configured by the user and stored in the device. The configured process steps are processed automatically by
the device. A wash-cycle may consist of several processes in which the samples are centrifuged, the
supernatant decanted, and then each sample tube is filled with a physiological saline solution and mixed.
The device should only be used by trained medical personnel in clinical laboratories and used only for the stated
purpose.
The life cycle of the device specified by the manufacturer is seven years. The lifetime of some parts of the
accessories is divergent and is specified in chapter 12.10 of this manual.
Any other use beyond this purpose, as well as non-observance of the intended use (see instructions in the
operating instructions regarding transport, storage and execution of cleaning, inspection and maintenance
work) is considered to be improper use. The company Hettich AG accepts no liability for any damage arising
from this.
2.1 Versions
The device is available in different configurations. If specific equipment features or functions are available only for
certain configurations, this is indicated at the relevant points in this manual. The functions described in this manual
refer to the latest software version. This manual was written in accordance with the software-version 1.01.421.
2.2 Storage and forwarding the operator-manual

This instruction manual belongs with the device and should always be stored where persons working on the
device have access to it. It is the responsibility of the owner to ensure that persons who are working or will work
on the device are informed as to the whereabouts of this operator manual. We recommend that it is always stored
in a protected location close to the device. Make sure that the instruction manual is not damaged by fluid or
humidity. If the device is sold on or transported and then set up again at a different location, the operator manual
must go with it.
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2.3 Responsibility of the owner
The owner of the device:
• is responsible for the flawless condition of the device and for its proper operation in accordance with the
specifications.
• is responsible for ensuring that persons who are to operate or service the device are qualified to do this,
have been instructed accordingly and are familiar with the operating manual at hand.
• must know about the applicable guidelines, requirements and operational safety regulations, and train
staff accordingly.
• is responsible for ensuring that unauthorized persons have no access to the device.
• is responsible for ensuring that the maintenance plan is adhered to and that maintenance work is carried
out properly (see chapter 12).
• must ensure that the device and its surroundings are kept clean and tidy, for example through
corresponding instructions and inspections.
• is responsible for ensuring that personal protective clothing is worn by operating personnel, e.g. work-
clothes, protective gloves.
• is responsible for ensuring that before starting work with this device all qualifications are released, the IQ
(Installation-Qualification), the OQ (Operational-Qualification) and PQ (Process-Qualification).
• is responsible for periodic routine to flush, clean and disinfect the device as well, described in chapter 12,
and take care of controlling the used fluid for the needed quality.
• is responsible for the use of the password-protection, user-settings (cha.8.6.2).
2.4 Requirements of the operating personnel

The device may only be operated and maintained by persons who are of legal age and have been instructed
accordingly. Personnel who are to be trained, instructed or who are undergoing general training may only work
with the appliance under the continuous supervision of an experienced person.
Repairs may only be performed by qualified electricians who are authorised to do so by the manufacturer. The
regulations in the separate service manual must be observed.
2.5 Changes and alterations

No unauthorized changes or alterations may be made to the device. No parts may be added or inserted which
have not been approved by the manufacturer.
Unauthorized modifications or changes result in the CE declaration of conformity losing its validity and the
device should no longer be operated.
The manufacturer is not liable for any damage, danger or injuries that result from unauthorized changes or
alterations, or from non-observance of the regulations in this manual.
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2.6 Warranty
No claim of warranty will be considered by the manufacturer unless ALL instructions in this manual have been
followed. Especially the flow-sensor and the magnetic-valve are excluded from a warranty exchange if they are
enriched with salt-crystals and this happens if the information in chapter 12 are not followed.
No claim of warranty will be considered by the manufacturer when an unauthorized modification is implemented
or non-authorized parts are installed.
3 Notes on safety
No claim of warranty will be considered by the manufacturer unless ALL instructions in this manual
have been followed.
The centrifuge should be installed on a good, stable base. We suggest that no other critical device, like
a balance, microscope or HPLC, is placed onto the same base.
The centrifuge should be set up so that no containers with e. g. liquids can fall down onto the
centrifuge
When the centrifuge is running, according to EN / IEC 61010-2-020, no persons, dangerous

substances or objects may be within the safety margin of 300 mm around the centrifuge.
Rotors, suspensions and accessories that possess traces of corrosion or mechanical damage or if their
term of use has expired may not be used any longer.
The centrifuge may no longer be put into operation when the centrifuging chamber has safety-related
damage.
For centrifuges without temperature control, when the room temperature is increased and/or if the device is
frequently used, the centrifuging chamber could be heated up. Therefore, it can't be ruled out that the sample
material might be changed due to the temperature.
Before the initial operation of your centrifuge you should read and pay attention to the operating instructions. Only
personnel that has read and understood the operating instructions are allowed to operate the device.
The centrifuge may not be operated in explosion-endangered areas.
The centrifuge should not be used with:

• inflammable or explosive materials
• materials that react with one another producing a lot of energy
Along with the operating instructions and the legal regulations on accident prevention, you should also follow the
recognised professional regulations for working in a safe and professional manner. These operating instructions
should be read in conjunction with any other instructions concerning accident prevention and environmental
protection based on the national regulations of the country where the device is to be used.
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This centrifuge is a state-of-the-art piece of equipment which is extremely safe to operate. However, it may pose
a risk to the user or third parties if it is not used by trained personnel, improperly or in accordance with its intended
purpose.
The centrifuge should not be moved or knocked during operation.
In case of fault or emergency release, never touch the rotor before it has stopped turning.
To avoid damage due to condensate, when changing from a cold to a warm room the centrifuge must either heat
up for at least 24 hours in the warm room before being connected to the mains.
Only the rotors and accessories approved by the manufacturer for this device may be used, see chapter “rotor
and accessories”. Before centrifuge tube-holders, reducers, which are not listed in the chapter “rotors and
accessories”, the user should make sure they can be used by asking the manufacturer of the device.
When centrifuging with maxim revolutions per minute the density of the materials or the material mixtures may not
exceed 1.2 kg/dm3.
The centrifuge may only be operated when the balance is within the bounds of acceptability
≤ 5g = pass and ≥10g = stop
If users centrifuge hazardous materials or compounds contaminated with toxic, radioactive or pathogenic micro-
organisms, they must take appropriate work-instruction measures.
Repairs must only be carried out by personnel authorised to do so by the manufacturer.
Only original spare parts and original accessories licensed by the manufacturer can be utilised.
Components contaminated with blood (e.g. rotor, centrifugation area, waste-tube and conectors) must, following
replacement, be disposed of in the special waste for materials contaminated with blood.
The following safety regulations apply:

EN / IEC 61010-1 and EN / IEC 61010-2-020 as well as their national deviations.
The safe operation and reliability of the centrifuge can only be guaranteed if:
• the centrifuge is operated in accordance with the operating instructions
• the electrical installation on the site where the centrifuge is installed conforms to the demands of
EN / IEC stipulations
• the tests for device safety required in the respective countries, e.g. in Germany in accordance with
“DGUV Vorschrift 3”, are carried out by an expert.
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4 Behaviour in case of malfunctions and irregularities
The device may only be used in a flawless condition. If you as the operator notice irregularities, malfunctions or
damage, immediately take the device out of work and inform your superior.
You can find on correcting malfunctions in chapter 13.
4.1 Remaining risks

The device is built according to the state-of-the-art and the recognized safety regulations. If used and handled
improperly, there could be life-threatening danger to the user or third parties, the device could be impaired or
there could be other property damage. The device is only to be used for its intended purpose and only when it is
in safe working condition. Malfunctions which could affect safety must be corrected immediately.
4.2 Switching off the device in an emergency

Push the on / off switch on the rear-panel to its off-position and disconnect the power plug. This
disconnects the device from the power supply at all poles.
4.3 Emergency release
The lid cannot be opened during power failure. An emergency release has to be executed by hand.
For emergency release disconnect the centrifuge from the mains.

Open the lid only during rotor standstill.
Only the plastic release pin provided may be used for emergency release.
• Switch off the mains switch (switch position "0").

• Look through the window in the lid to be sure that the rotor has come to a standstill.
• Insert the release pin horizontally into the hole. Push the unlocking pin in until the handle can be lifted when
the pin is pressed in.
• Open the lid.
• An error appears on the display after switching on the centrifuge.
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5 Technical specifications
Modell Rotolavit II Rotolavit II-S

Part-Nr. 1008-00 1008-03 1008-00S
Ext. power-supply 100–240 V~
Mains frequency 50–60 Hz
Protection class class I
Connected load 144 VA
Current consumption 0,7 A (230 V~) or 6 A (24 V=)
Power 150 W
Fuse 10 A / 250 V F
Optional car-battery DC- no 11–30 VDC no

input
Width 330 mm / 13inch
Depth 480 mm / 18,9inch
Height, closed lid 280 mm / 11inch
Height, open lid 580 mm / 22,9inch
Weight kg / lb 24,4 / 53,8 24,7 / 54,5 24,4 / 53,8
Capacity, standard 12 x 5 ml
Capacity (optional) 24 x 5 ml
Speed / Radius 3500 RPM / 105 mm
force 1438 RCF
Kinetic energy, max. 250 Nm
Max. allowed density 1,2 kg / dm3
Obligatory inspection
no
(BGR 500)
EMC IEC61326-3-2 / FCC CFR47, part 15, ed 2015, class b
Noise level 62dB 62dB 62dB
Ambient conditions Not suitable for use in explosion endangered areas
EN / IEC61010-1 indoors only
up to 2000m above sea level
Altitude ambient
Ambient temperature 18 °C to 30 °C
Humidity 20 %rF to 80 %rF / nicht kondensierend
Storage temperature 5 °C to 50 °C / max. 60%rF

tab. 1.0
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6 Unpacking the centrifuge
If packaging arrives damaged, it must be confirmed by the carrier and the centrifuge must be specially
inspected.
To avoid damage, do not unpack the appliance until you reach the installation site.
Check the delivery note to ensure that the delivery is complete. Check the appliance for damage.
Take care, you could injure your skin on the edge of the cardboard packaging carton.
Lift the centrifuge on both sides and not on the frontpanel. Take it out of the box with an adequate
amount of people to help you.
According to the laboratory instrument standards EN / IEC 61010-2-020 an emergency switch to

disconnect the power supply in the event of a failure must be installed in the building electrical system.
This switch has to be placed remote from the centrifuge, preferably outside of the room in which the
centrifuge is installed or near by the exit of this room.
Before the centrifuge is connected to the power or the lid is opened using the emergency opening,
place the centrifuge carefully on one side so that the three transport locking screws on the underside
of the centrifuge can be removed with the help of the enclosed hexagon L-key wrench. Carefully place
the centrifuge back on its feet, connect the power correctly, and operate the centrifuge and open the
lid, so that the transport foam of the supplied rotor, or the additional transport lock on delivery without
rotor, can be removed.
Position the centrifuge in a stable and level manner in a suitable place. During set-up, the required
safety margin of 300 mm around the centrifuge is to be kept according to EN / IEC 61010-2-020.1
When the centrifuge is running, according to EN / IEC 61010-2-020, no persons, dangerous
substances or objects may be within the safety margin of 300 mm around the centrifuge.
If you notice deviations from the delivery note, damage or irregularities, do not put the appliance
into operation, but inform the haulage company and your supplier.
If possible, keep the transportation material and the transportation safety device in a safe and dry place.
6.1 Storage after delivery

If the device must first be stored after delivery, then check the box from outside for damage and if it is so,
inform the haulage company and your supplier immediately. For the storage conditions, refer to tab. 1.0
technical specifications.
6.2 Installation after storage

If the storage environment was outside the working environment, then you must allow the device to acclimatise
to the new environment for 24 hours without connecting to the power.
15
6.3 Delivery checklist
1 power-supply, fig. 7.2.4
1 drainage hose ( 14,3 mm) with connector, E4374, fig. 7.2.3
1 fill hose ( 7,1 mm) with connector, E4373, Inlet 1, with intake pipe; for the physiological saline solution,
E4373
1 fill hose ( 7,1 mm) with connector, Inlet 2 (Fluid 2), with intake pipe for a secondary solution *1
1 angle piece (plastic), for the drainage hose (for free-running drain), E4394, fig. 7.2.1
1 power-cord
1 battery-cord (with open wires) *2
1 release-pin, E2287, fig. 7.2.1
1 hex L-key, fig. 7.2.1
The rotor(s) and associated accessories are included in the delivery in the quantity ordered.
*1 would be delivered only for devices with the optional secondary pump (p/n 1008-02 and
1008-04)
*2 would be delivered only for devices with the optional car battery DC-input (p/n 1008-03
and 1008-04)
6.4 Disposing of packaging material

Dispose of the packaging material (cardboard, polyurethane foam, tie and plastic bag) in accordance with the
applicable disposal regulations for the respective material in your country. If you have any questions, please
contact your local supplier. We recommend to keep at least one set of the original packaging for transporting
(Chap. 6.5).
6.5 Transportation
Please store the original packaging and use it for transportation. If you have to transport the device and you do
not have the original packaging material anymore, please contact your local supplier. The device and its motor
and rotor must be protected during transportation.
16
7 Installing the wash centrifuge
7.1 Connections
1 solution tube to the lid
2 mounting bracket for the power-supply
3 ON / OFF main switch
4 Ethernet interface 1
5 DC power input *
6 fuse, fuse holder
7 inlet1, saline
8 inlet 2, solution 2*
9 outlet, drain 2
* Refer to the technical specifications comparing to

The part number from your device, tab 1.0
4 5 6 7 8 9
fig. 7.1
9 Emergency release hole

(Refer to chapter 4.3)
Fig. 7.2
If you use the device connected to a car- or truck-battery without the option, then the device could
become damaged.
Refer to the technical specifications comparing to the part number from your device, tab 1.0
Allow the option to be installed only from an authorised distributor.
If you install the device in a car, truck, ship or another mobile environment, then you must protect
the device with the transportation foam during transportation and you must ensure that the ambient
conditions are conform to the tec. Specifications.
17
7.2 Accessory
E4394, angle piece E4373, fill-hose,

Inlet 1, complete
E2287, emergency- E4261, plug,
release pin anschluss, input 1
hex L-Key E4258, weight for

suction tube
Fig. 7.2.1 Fig. 7.2.2
E4374, drain hose, complete
E4259, plug, for waste tube
Fig. 7.2.3
E4251 / E4502, power-supply
Fig. 7.2.4
The Angle piece is for the drain hose. This ensures that the liquid runs off and no siphon is created.
If liquid back into the device and fills the bowl, your device (motor) will be damaged.
Fig. 7.2.5 Fig. 7.2.6
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7.3 First steps
Please check chapter 3 before starting the installation.
Install the power supply in its mounting bracket on the rear side (see Fig. 7.1, Pos. 2) and plug the connector to
the DC input (Fig. 7.1, Pos. 5). Plug the provided main power cable into the power supply and the other side to
the power source.
Check the country-specific regulations when making connections (e.g. in Germany with
residual current circuit breaker). Observe the connection and power ratings, see on the label
and the technical specification. Make sure to establish a safe PE conductor connection.
Lay the power cable so that

• it is always accessible and within reach, so it can be disconnected in the event of
a failure
• no one can trip over it
• it does not have contact with a solution, e.g. water or saline, mechanical parts, e.g.
shakers or mixers, or hot parts, e.g. ovens or torches
Plug the connector from the fill hose to the inlet 1 on the rear side (Fig. 7.1, Pos. 7) and dip
the other side with the suction-tube into the container with the saline solution.
If the fill hose is too short for your installation and it is not possible to move the can with the
solution closer and you need an oversized fill hose (from your local distributor), then you must
validate the flush- and the refill pump programs for correct operation.
If your device has the optional inlet 2, plug the connector from the fill hose 2 to the inlet 2 on
the rear side, see on fig. 7.1, Pos. 8 afterwards dip the other side with the suction tube into
the container with the fluid 2 solution.
Ensure that it is not possible to interchange the ends from the tubes and the cans or
containers, otherwise all probes will be disturbed!
Plug the connector from the drainage hose to the outlet on the rear side, see on fig. 7.1 pos.
9, and put the other side into the waste.
Ensure that the drainage hose lies flat onto the base, if not and it is like figure 7.2.6, the
device will become damaged.
Clean and disinfect the device before first use.
19
fig. 7.4 fig. 7.3
seal
splash guard receiver
splash guard cap
centrifugation area
bowl
inscription (just on fig. in red)
lid lock access hole
fig. 7.5
handle to lift the rotor
marking for positioning the rotor
fig. 7.6
20
7.4 Starting the wash centrifuge
Push the ON / OFF main switch (fig. 7.1, Pos. 3). The start initialization needs approx. one minute.
When the main screen appears push the lid-open button and open the lid, chapter 8.2 pos.7, remove the
transportation safety device from the top of the rotor and keep it in a safe place.
7.5 Install and remove the rotor

Either a 12-place rotor or a 24-place rotor may be installed in the Rotolavit II and Rotolavit II-S. Both rotors can
hold either 10 mm x 75 mm tubes or 12 mm x 75 mm tubes, glass- or plastic-types. A rotor must be installed
and the setup must be correctly to operate, see cha. 8.5 systems settings and cha. 10.1 Entering the rotor-
type.
Rotor installation procedure:

1. Grasp the rotor on the grip area (fig. 7.6, pos. 1) and place the rotor over the motor-axis.
2. Align the markings (fig. 7.6, pos. 2) on the top of the rotor with the slots on the motor-axis.
3. Lower the rotor onto the motor-axis.
If the rotor is placed incorrectly over the motor-axis, then it is not possible to close the lid.
Rotor removal procedure:

1. Open the lid.
2. Grasp the rotor on the grip area and lift the rotor straight up.
21
8 Operation settings
8.1 Overview
Operation settings for the Rotolavit II can be viewed and changed through the system settings menu.
Software version: 1.01.421 Legend:
Service
user
Advanced
user
22
8.1.1 Password protection
Some operating functions are restricted for the "Normal User" level and some can be restricted (R) in the "User
Settings" menu, see chapter 8.6.2. But to do this, the service user password is needed. On delivery the
password for the Advanced User is “1008” (name can be changed), see also the following table:
If you have to be logged in for an action with a password, it is specified in this manual with [Login].
Function for software rev. 421 Normal user Advanced user Service user Factory user
select program √ (R) √ √ √
start program √ (R) √ √ √
check function √ (R) √ √ √
abort program (stop) √ (R) √ √ √
add / edit program √ √ √
select rotor type √ (R) √ √ √
view history √ √ √ √
reset rotor operating time √ √
change time / date settings √ √ √
add / change / delete Adv. User Name √ √
add / change / delete Adv. User Password √ √
calibrate filling volume √ √
change device settings √
change password √ √
8.2 Start screen
1 1. name of the selected program

2. start program [Login]
3. standby, dark display, reduced power
2 4. system settings, device settings
5. login / logout
6. select a program
7. open lid
3 4 5 6 7
The service user can restrict for the normal user the possibility to start a program.
23
8.3 Select program
1. existing programs
1 2. add a new program [Login]
3. navigate through the existing program listing
4. back to start screen
2 4
3
The individual programs must be matched or validated by the operator to the customer-specific tubes.
8.4 Add a new program

1 1. rename program [Login]
2. add process [Login]
3. select an existing process of the program [Login]
2 4. edit process [Login]
6 5. back without saving [Login]
6. navigate through existing processes [Login]
4 5
3
8.5 System settings
It is necessary to enter the rotor type used (12-place or 24-place) in order to calculate the filling volume
and it is only possible to enter the rotor type when the rotor has stopped.
1. time-, date- and language settings [Login]

1 2. change rotor type [Login]
3. beep at the end of a program
4. brightness control
2
3 4 5. beep volume control
6. save changes
7. service menu [Login]
5 8. History
9. edit password [Login]
6 8 9 10 10. back without saving
7
24
8.5.1 History
1. last or next month

1
1 2. return to system settings
The days with a highlighted background have

some saved data / runs.
Is the history date far from the current date, switch off the device (from that screen) with the main
switch, wait 10 seconds and switch on again, the next time the history is selected, the current date will
appear.
8.5.2 Language, date and time settings
Wheel adjuster for language, date and time

preferences [Login]
1. accept changes
2. discard changes and return to system settings
1 2
After changing the language, a restart must be performed.
8.5.3 Edit password
1. insert old password [Login]

1 4 2. insert new password [Login]
3. repeat new password to confirm [Login]
2 4. show / hide passwords verbergen [Login]
3 5. accept changes [Login]
6. discard changes and return to settings[Login]
25
8.6 Service menu
1. calibration [Login]
2. user settings [Login]
3. device settings [Login]
4. network settings [Login]
5. back to system settings [Login]
5
1 2 3 4
8.6.1 Calibration
Screen 1
1. select pump [Login]

2. select target for measurement [Login]
3
3. correct by 1ml [Login]
1 2 4. correct by 0.1ml [Login]
4
5. target measure [Login]
6. open lid [Login]
5 7. fill in solution
8. start calibration
9. back to service menu without calibration
6 7
8 9
Screen 2
10. indicate filling level [Login]

11. accept and save the calibration
12. discard calibration
10
11 12
26
8.6.2 User settings
1. select / deselect user rights [Login]

2. delete user [Login]
2 3. set password [Login]
4. add a new user [Login]
1 5. go upward in user list[Login]
3 6. go downward in user list [Login]
4 7. save users [Login]
8. back to service menu without saving [Login]
5 6 7 8
Only the “service user” can generate a new “advanced user” and restrict or change the rights of the
“normal user” account (without a login), e. g. change the green “tick” to a red “X” so that the “normal
user” account cannot select the “Check” button during a run.
The password for the “advanced user” is “1008” and should be personalized accordingly during
installation. The “advanced user” does not have access to the device settings and the calibration
menu.
8.6.3 Device settings
Screen 1
1. change device name [Login]

2. use new rotor [Login]
1 3. open the lid at the end of a run
[Login]
3
4. save changes [Login]
5. go to second screen [Login]
2
4 5
Do not confuse the lid option with the „CHECK-process. By activating the lid option, the device
will open the lid after every finished run or if an error occurs.
27
Screen 2
6. activate / deactivate pump [Login]

7. define motor speed limit
[Login]
7
6
Factory setting: pump 1 = on, pump 2 = off, motor speed limit = 3500rpm, device name = 1008 (or
1008 03), rotor = the date corresponds to the manufacturer’s end-control.
8.6.4 Network settings
1. current network settings [Login]

2. save chganges [Login]
1 3. back to service menu without saving
[Login]
2 3
9 Programs
9.1 Starting the program

Start screen:
„decant“ is the actual loaded program.
Push „Start program“, to start.
1. Push this button to select a different program
28
Select a program.
To add a new program
see chapter 8.4.
Each program must be validated by

the user with the custom tube. If the
tube is changed, then the program
must be revalidated!
After selecting the program each

process is displayed.
Check the program and all settings

For each process!
To load the program push:
The now loaded program name

is displayed.
Push „Start program“ to start.
29
The program starts and the ongoing
process is highlighted.
Push „CHECK“ and the lid will open as soon

as the ongoing process is finished.
9.2 Stop a running program
To stop the program, push „STOP“.
Confirm with:
Back with:
30
9.3 Pre-installed programs
1. Pre-installed system programs
1 2. Pre-installed user programs for the device types

1008-00 and 1008-03
Pre-installed user programs only for the

2 device type 1008-00S:
2 - cell recovery
- immunophenotyping
9.3.1 flush
This pre-installed system program is designed to flush (clean) the external and the internal tubing system with
deionized or demineralized water after the routine so no salt crystals are built.
Before the routine, the tube system must be rinsed with saline.
If you delete this program, only a specialist can reload it.
9.3.2 refill pump
This pre-installed system program is designed to refill the external and the internal tubing system with the used
and needed solution without spinning the rotor. It will also ignore air bubbles in the system.
If you delete this program, only a specialist can reload it.
31
9.3.3 wash redcells 3 5ml 3x (wash erythrocytes, 3.5 ml, 3 x)
This preinstalled program is visualized as an example.
The process values are:

− FILL 3.5ml 1100rpm (fill with 3.5 ml by 1100rpm)
− SPIN 20sec 3500rpm (acceleration 800rpm/s), braking 1000rpm/s)
− DECANT 390rpm (decant by 390rpm)
− AGIT 15x (15 agitations)
− LOOP 3x (two more runs, a total of three wash cycles)
one cycle run through 1 run through 2

LOOP 1 LOOP 2 LOOP 3
P2
FILL SPIN DCNT AGIT LOOP 2 of 3 LOOP 3 of 3

(Bef (zentr (deka (two more runs) (one more run)
üllen ifugie ntiere
) ren) n)
9.3.4 agit and spin

− SPIN 20sec 3500rpm (acceleration 800rpm/s, braking 1000rpm/s)
9.3.5 decant

− DECANT 390 rpm (decant by 390rpm)
9.3.6 spin 20sec 3500rpm

9.3.7 susp 3 5ml spin 20sec (centrifuge 3.5ml suspension for 20sec)

− FILL 3.5ml 1100rpm (fill 3.5 ml at 1100rpm)
32
9.3.8 wash 3 5ml 3x and anti (wash 3.5 ml, 3 x, plus antihuman globulin test)

− FILL 3.5ml 1100rpm (fill 3.5ml by 1100rpm)
− LOOP 3x (two more runs)
− CHECK Pause (to add the antihuman globulin manually)
−
9.3.9 wash white cells Tspot (wash leukocytes, Tspot)

− SPIN 7min 2260rpm (acceleration 800rpm/s, braking 1000rpm/s)
− LOOP 2x (only one more run)
9.3.10 cell recovery (only device type 1008-00S)

9.2.11 immunophenotyping (only device type 1008-00S)

− DOWN 1100rpm
− FILL 0.5ml 1100rpm (fill 0,5ml by 1100rpm)
33
9.4 Process descriptions
9.4.1 Principle
A program can have a maximum of 20 different processes, but only with 1 LOOP process. It does not matter
with which process a program starts, except with a LOOP process or a CHECK process and it can also have
only one of these processes.
9.4.2 FILL 1 process
Add the physiological saline directly into the tubes

via the distributor of the rotating rotor to get a good
resuspension of the cells. For this purpose, a speed
range from 0 rpm to 2500 rpm is available. The fill
volume to be set per tube is between 0.1 ml and 10
ml. The default value is 3.5 ml at 1100 rpm.
The best results are with a speed of 1100 rpm for both kinds of rotor types.
The device will calculate the complete volume itself for the preselected rotor.
9.4.3 FILL 2 process
Filling in the secondary solution.

For this purpose, a speed range from 0 rpm to 2500
rpm is available. The fill volume to be set per tube is
between 0.1 ml and 10 ml. The default value is 3.5
ml at 1100 rpm.
Only selectable if your device has installed the optional second pump
(part number 1008-02 and 1008-04)
34
9.4.4 DOWN process
Down:
The number of revolutions per minute is adjustable
from 0 rpm to 3500 rpm. The time duration is
adjustable from 0 s to 20 s. The default value is
2000 rpm and 5 s.
Centrifugation run to centrifuge the remaining
droplets on the inner-side of the tubes to the bottom
of the tube.
9.4.5 SPIN process
Page 1/2
Sedimentation:
from 0 rpm to 3500 rpm. The time duration is
adjustable from one second to two hours (0:00:01 to
2:00:00). The default value is 3500 rpm and 30
seconds (0:00:30)
The erythrocytes are sedimented by a selectable

rotation speed. The time only begins to count after
the set rotation speed is reached. After the time has
elapsed, a quick braking follows to prevent a
resuspension of the pellet.
Page 2/2
The default value for the acceleration is 800 rpm/s.

The default value for the braking is 1000 rpm/s.
For the page change press onto the SPIN-icon
It is not possible to work with an endless spin process.

If it is necessary to work with a longer single spin process, it is possible to add a loop process for the
desired time-duration of max. 200 hours (with more processes to an absolute maximum of 3800 h)
35
9.4.6 DECANT process
Decanting:
from 0 rpm to 2500 rpm. The excess is decanted at
the selectable rotation speed. During decanting, the
rotor turns in the opposite direction of the normal
rotation so that the solution will be decanted. The
default-value is 370 rpm.
The correct speed must be validated with the used tubes for the best possible results because the
different inner surfaces of the tubes, e.g. glass tubes or plastic tubes. You will also get different results
when the speed is optimized for 10mm tubes but the used tubes are 12mm tubes.
If the DECANT speed is too high then it is possible that the washed cells will also be decanted.
If the speed is too low, you will probably have too much liquid in the tubes and with the next FILL
process the tubes will be overfilled.
9.4.7 AGIT process
Agitating, shaking:
The numbers of shakings are adjustable from 0x to
500x. The default value is 15x. The pellet is loosened
again for the subsequent wash cycle by a fast, brief
movement of the rotor and the tube holders.
36
9.4.8 LOOP process
Loop.
This process only makes sense as a following
process from a minimum of one other process. The
numbers of loops are adjustable from 1x to 100x.
The default value is 3x. After the foregone process is
finished, all foregone processes will be repeated with
the adjustable value minus 1.
If the foregone process is a spin process with a duration time of 2 hours and the loop process is
adjusted to 2x, then the program will repeat the spin process once with a duration of 2 hours, which
means that the device spins for 4 hours.
After the LOOP process you can add every other process except a LOOP process, that means you
can program to wash out cells with two cycles instead of three with a DECANT process with a speed
of approx. 320 rpm. With this speed a small amount of solution will stray into the tubes and after the
LOOP process you add the same processes again, but the speed from the DECANT process is
around 370 rpm; with this the tubes have the solution emptied.
9.4.9 CHECK process
Check, pause:
This process only makes sense as a following
process from a minimum of one other process. After
the foregone process is finished the program will be
paused and the lid will open. The user can check the
probes or can add some other fluids to the probes
with a pipette. When the lid is closed, the program
will continue.
If the forgone processes is a wash cycle and you added the anti human globulin serum during the
check process, the following processes are necessary: AGIT-process or SPIN-process.
37
9.5 Add a new program
Go to the signs on the right:
• To select a program push:
• To add a new program push:
• To add the first process push:
• To edit the name push

at the top:
In this example, the first process is

“FILL”
• Push the „FILL 1“ symbol
• Below the symbol you can

choose the filling capacity and
the rotation speed at which it
should be filled.
To accept the FILL 1 process

push:
To add another process, click:
38
In this example, add the process “Spin”:
• Push the „SPIN“ symbol
• Below the symbol you can choose rotation

speed and the duration of the process.
On the second page you find the
acceleration- and braking speed by clicking:
• To accept the SPIN process push:
• To add more process push:
• By selecting a process, you can switch the

process to the previous process position
• To switch left push:
• Or after the next process position to the

right push:
• To edit a process select it and

Push below:
• To save push:
• to view processes 6 to 10, 11 to 15 and 16

to 20, push at the right side, backwards at
the left side
Each program must be validated with a minimum of 12 probes with a 12-place rotor and equivalent
24 probes with a 24-place rotor and compared with another device or method.
39
If you change the used tubes, e.g. the size or from plastic style to glass style, or the supplier doesn’t
support the used tubes anymore, you must revalidate all used programs.
10 Adjusting
10.1 Entering the rotor type
It is necessary to enter the rotor type used (12-place or 24-place) in order to calculate the filling
volume. It is only possible to enter the rotor type when the rotor has stopped.
To adjust settings:
• Go to system settings (start screen, cha. 8.2, pos. 4)
• Change to the actual used and inserted rotor type, 12-place or 24-place (cha. 8.5, pos. 8)
• Save the setting and go back to the start screen with the button save changes (cha. 8.5, pos. 6)
10.2 Calibrating the filling volume

• Go into the system settings (start screen, cha. 8.2, pos. 4)
• Go into the service menu (system settings, cha. 8.5, pos. 7)
• Go into calibration (service menu, cha. 8.6, pos. 1)
• Open the lid (cha. 8.6.1, pos. 6)
• Check that the 36ml target is green for the use of a 50ml graduated measuring cylinder, conform to
DIN/EN/ISO 4788 and equivalent for the 72ml target for a 100ml cylinder.
• Remove the rotor and hold a cup underneath the injection tube and push the button fill in solution (cha.
8.6.1, pos. 7) and ensure that no air bubbles are in the solution tube at the back side of the lid (fig.7.1,
pos. 1)
• hold a cylinder underneath the injection tube inside from the lid and push the button start calibration
(cha. 8.6.1, pos.8)
• Adjust the reading from the cylinder at the target measure (cha. 8.6.1, pos. 10) with the buttons “+” or “-
“ graduate decimal point 0.1ml and “++” or equivalent “- -“ graduate decimal point 1ml.
• Accept the calibration (cha. 8.6.1, pos. 11) or discard the calibration (cha. 8.6.1, pos. 12)
• If it was necessary to adjust the calibration, then check the calibration again.
• Exit with the button go back to the service menu (cha. 8.6.1, pos. 9)
Do a calibration check:
• Weekly
• Before a validation
• After maintenance
40
10.3 Audible signal
The following audible signals are programmed:
• 2 second intervals if an error occurs
• in 10 second intervals after the program has ended and the rotor has stopped.
• The audible signal can be stopped by opening the lid or by pushing any button.
o The signal after completion of the program can be activated or deactivated in the following manner, if
the rotor is at standstill:
o To adjust the volume, go at the start screen and push the button for the system settings
(cha. 8.2, pos. 4)
o Adjust the volume by varying the slider at the bar (cha. 8.5, pos. 5), at the far left side, the audible
signal is deactivated.
o Select your preferred mode for the audible signal after the program is ended with only one beep or
with an endless interval of 10 seconds for one hour.
o Confirm it with the button save changes (cha. 8.5, pos. 6).
If an alarm or the program end beep is running then the standby mode will activate till after 60 minutes
instead of the normal 10 minutes, but the display will go to dark mode after 10 minutes instead of the
normal 5 minutes.
10.4 Relative centrifugal force (RCF)

The relative centrifugal force (RCF) is given as a multiple of the acceleration of gravity (g). It is a unit-free value
and serves to compare the separation and sedimentation performance.
These values are calculated using the formula below:
RPM 2  RCF
RCF =( ) x r x 1,118 RPM=√ x 1000
1000 r x 1,118
RCF = relative centrifugal force

RPM = rotational speed (revolutions per minute)
r = centrifugal radius in mm = distance from the centre of the turning axis to the bottom of the tube,
see cha. 16.1, Rotors and accessories.
The relative centrifugal force (RCF) stands in relation to the revolutions per minute and the
centrifugal radius.
10.5 Querying operating hours

Go into the system settings (start screen, cha. 8.2, pos. 4)
Go into the service menu (system settings, cha. 8.5, pos. 7)
41
11 Centrifugation of materials or mixtures of materials with a
density higher than 1.2 kg / dm3
When centrifuging with max. revolutions per minute, the density of the materials or the material mixtures may not
exceed 1.2 kg/dm3.
The speed must be reduced for materials or mixtures of materials with a higher density.
The permissible speed can be calculated using the following formula:
1.2
reduced speed (nred) =√ x maximum speed [RPM]
greater density [kg/dm3]
e.g.: maximum speed RPM 3500, density 1.6 kg/dm3
1.2 kg/dm3
nred =√ x 3500 RPM = 3031 RPM
1.6 kg/dm3
In the exceptional case that the maximum loading indicated on the hanger is exceeded, the speed must also be
reduced.
The permissible speed can be calculated using the following formula:
maximum load [g]

reduced speed (nred) =√ x maximum speed [RPM]
actual load [g]
e.g.: maximum speed RPM 3500, maximum load 300 g, actual load 350 g
300 g
nred =√ x 3500 RPM = 3240 RPM
350 g
If in doubt you should obtain clarification from the manufacturer.
12 Maintenance and servicing

The device can be contaminated.
Pull the mains plug before cleaning.

For safety reasons, you must wear gloves and a respiratory mask when cleaning the
equipment used for blood processing.
Before any other cleaning or decontamination process other than that recommended by the
manufacturer is applied, the user has to check with the manufacturer that the planned process does
not damage the device.
• Centrifuges, rotors and accessories must not be cleaned in rinsing machines.

• They may only be cleaned by hand and disinfected with liquids.
• The water temperature must be between 20 – 25°C, 68°F – 77°F.
• Only detergents/disinfectants may be used which:
− have a pH between 5 - 8
− do not contain caustic alkalis, peroxides, chlorine compounds, acids and alkaline solutions
• To prevent appearances of corrosion through cleaning agents or disinfectants, the application guide from the
manufacturer of the cleaning agent or disinfectant must be heeded.
• Certain preservation agents in acid-free saline solutions can cause long-term damage to the plastic parts in
the device. Regular cleaning prevents salt deposits and lengthens the life span of these parts.
42
12.1 Centrifuge
• The following must be carried out daily:
− Check the tubes and their attachments. The tubes must not be cracked or blocked and must be
securely attached. Do not forget the solution tube to the lid (fig. 7.1, pos. 1). The used saline solution
must be allowed to flow off freely through the drainage hose.
− The centrifugal area must be clean and free from dried up salt crystals and other deposits. Clean the
centrifugation area, the splash guard receiver and the splash guard cap with a moist cloth or sponge.
The splash guard receiver and the covering ring can be removed from the centrifugation area for
cleaning, refer to Chapter "Removal of the splash guard receiver and cap".
− Check the filling volume of the saline solution container (see the “Adjusting the filling volume” chapter
10.2).
− The system must be rinsed through with distilled water to avoid formation of salt crystals, refer to
Chapter "12.5 Flushing system with deionised or distilled water".
• It is important that the tubes are kept clean and free from dried up salt crystals and other deposits.
• The system must be regularly cleaned, refer to Chapter "12.6 ". It is recommended to clean the appliance at
least once a week.
• Clean the centrifuge housing and the centrifuging chamber regularly, using soap or a mild detergent and a
damp cloth if required. This serves as hygiene protection and prevents corrosion caused by impurities.
• Ingredients of suitable detergents:
soap, anionic tensides, non-ionic tensides.
• After using detergents, remove the detergent residue by wiping with a damp cloth.
• The surfaces must be dried immediately after cleaning.
• Lightly rub the rubber seal of the centrifuge chamber with talcum powder or a rubber care product after each
cleaning.
• Surface disinfection:
− If infectious materials penetrate the centrifugal chamber this is to be disinfected immediately.
− Ingredients of suitable disinfectants:
ethanol, n-propanol, isopropyl alcohol, glutardialdehyde, quaternary ammonium compounds.
− After using disinfectants, remove the disinfectant residue by wiping with a damp cloth.
− The surfaces must be dried immediately after disinfecting.
• Removal of radioactive contaminants:
− The agent must be specifically labelled as being an agent for removing radioactive contaminants.
− Ingredients of suitable agents for removing radioactive contaminants:
anionic tensides, non-ionic tensides, polyhydrated ethanol.
− After removing the radioactive contaminants, remove the agent residue by wiping with a damp cloth.
− The surfaces must be dried directly after removing the radioactive contaminants.
• The centrifuging chamber is to be checked for damage monthly and after glass breakage
• If the lid not stops wherever it will be released, then notify the Customer Service to replace both hinge together
If damage is found which is relevant to safety, the centrifuge may no longer be put into operation. In
this case, notify Customer Service.
43
12.2 Rotor
• It is important that the rotor is kept clean and free from dried up salt crystals and other deposits.
• Either soak the rotor in warm, distilled water or pour the water directly down into the rotor for a few minutes.
The water must flow out of all the injection nozzles.
• If the injection nozzles are blocked, insert the included plastic pin into the injection nozzles and carefully slide
it in and out until the nozzles become clear again.
• In order to prevent corrosion and material changes, rotors and accessories must be cleaned regularly with
soap or a mild detergent and a damp cloth. Cleaning is recommended at least once a week. Contaminants
must be removed immediately. Ingredients of suitable detergents:
soap, anionic tenside, non-ionic tenside.
• After using detergents, remove detergent residue by rinsing with water (only outside of the centrifuge) or wipe
off with a damp cloth.
• The rotors and accessories must be dried directly after cleaning.
• Disinfection:
o If infectious material should get on the rotors or accessories, they must be appropriately disinfected.
o Ingredients of suitable disinfectants:
glutaraldehyde, propanol, ethyl hexanol, anionic tenside, corrosion inhibitors.
o After using disinfectants, remove disinfectant residue by rinsing with water (only outside of the centrifuge)
or
o wipe off with a damp cloth.
o The rotors and accessories must be dried directly after disinfection.
o Removal of radioactive contaminants:
o The agent must be specifically labelled as being an agent for the removal of radioactive contaminants.
o Ingredients of suitable agents for removing radioactive contaminants:
o anionic tenside, non-ionic tenside, polyhydrated ethanol.
o After removing the radioactive contaminants, remove agent residue by rinsing with water (only outside of
the
o centrifuge) or wipe off with a damp cloth.
o The rotors and accessories must be dried directly after removing the radioactive contaminants.
o The rotor is to be checked for corrosion damage every month. The rotor is to be checked for corrosion
damage every month.
If there are signs of wearing or corrosion, e.g. cracks in the material, the rotors and accessories must
no longer be used.
12.3 Autoclaving
The system must be regularly disinfected and cleaned, refer to Chapter 12.6 Clean system.
No parts from the device and its accessories are made for autoclaving.
44
12.4 Removal of the splash guard receiver and cap
The splash guard receiver and the splash guard cap can be removed from the bowl (fig. 7.5), centrifugation
area, (fig. 7.5), for cleaning.
Removal of the splash guard receiver and the splash guard cap:
• Remove the splash guard cap (fig. 7.5) from the bowl (fig. 7.5)
• Carefully flap the inner sealing ring (fig. 7.5) upwards and remove the splash guard receiver (fig. 7.5) out of
the centrifugation area.
Installation of the splash guard receiver and splash guard cap:

• At the back of the centrifugation area carefully flap the sealing ring (fig. 7.5,) upwards and push the splash
guard receiver (fig. 7.5) under the sealing ring (fig. 7.5)
The drain hole of the splash guard receiver must be located above the drain hole in the bowl
• Carefully flap the sealing ring upwards around the splash guard receiver on the inside and press the splash
guard receiver carefully downwards. The splash guard receiver (fig. 7.5) must be located below the sealing
ring (fig. 7.5).
• Place the splash guard cap (fig. 7.5) onto the splash guard receiver in such a way that the inscription "this
side up" can be read, refer to fig. 7.5 (in red)
12.5 Flushing the system with deionized or distilled water

• Take off the saline-tube, solution 1, from the physiological saline solution container and dip it into the provided
flask with deionized or distilled water
• Start the system-program “flush”
• Take off the saline tube from the flask and dip it back into the saline solution container
• Open the lid and dry the centrifuging area
Keep the deionized or distilled water in the system until you start with the next wash procedure to
protect the system from crystallized salt crystals.
Take care to rinse the system with the flush-program before starting any other program, otherwise the
probes will be disturbed.
12.6 Cleaning the system with cleaning solution

• In a beaker, prepare about 400ml of 0.5% sodium hypochlorite cleaning solution, also prepare deionized or
distilled water in a flask
• Take off the saline tube, solution 1 from the physiological saline solution container and dip it into the beaker
with the 0.5% sodium hypochlorite cleaning solution
• Wait 5 minutes
• Take off the saline tube from the beaker and dip it into the flask with deionized or distilled water
• Open the lid and dry the centrifuging area
• Take off the saline tube from the flask and dip it into the saline solution container
• Start the system program “flush”
• Check the filling volume by doing the procedure “10.2 calibrating the filling volume”
• Take off the saline tube from the saline solution container and dip it into the flask with deionized or distilled
water
• Start the system program “flush”
• Keep the deionized or distilled water in the system until you start with the next wash procedure and take care
to rinse the system with the flush program before starting any other program
45
12.7 Glas breakage
In a case of glass breakage, the pieces of glass and leaked centrifugal liquid must be carefully removed from
the centrifugal area and tube holders.
The leakage could involve infectious materials, the area must be disinfected immediately.
The drain hole from the bowl should be blocked, for example, with a plug, pencil rubber or with a
crimped over tissue, so that no pieces of glass can fall into the drain-hole and block the drain outlet
connector on the rear side of the device, fig. 7.1, pos. 9, before starting to remove all broken pieces of
glass.
Before continuing to work:
• The bowl must be checked for scratches, if present a technician must replace it => call your local
distributor.
• The tube holder, where a tube was broken must be replaced, the rotor and its tube holders must be
checked for scratches and the rotor must be checked for correct function, if so or you are unable to
resolve that, then the rotor must be replaced.
Take care never to use tubes which
• have fallen to the floor

• have cracks in the glass
12.8 Repairs
Repairs and periodic maintenances of the device (internally where it is necessary to open the case)
must be done ONLY by the manufacturer’s authorised employees. ONLY original parts, authorised by
the manufacturer, must be used for repair
12.9 Rotor crash

WARINING In a case of a rotor crash you must immediately contact the manufacturer or your local service
support to ask for instructions before you touch the device or some piece of it.
If you cannot reach somebody, then take pictures from different views and you are allowed to
inject the device and the surrounding area with a disinfectant, but not anything else!
46
12.10 Maintenance schedule
Recommended minimum requirements. Regulations for your organization or physical conditions at your
organization may require maintenance items to be performed more frequently and or only by designated service
personnel.
Task Frequency
daily weekly monthly annually
Inspect the tubing and drain and clear obstructions if X
necessary
Inspect the tubing connections and secure them if X
necessary
Flush the system with deionized or distilled water X
Clean and dry the interior after normal usage to prevent X
corrosion and contamination
Flush the system with cleaning solution X
Clean the fill ports on the rotor X
Check the saline volume setting and calibrate it if X X
necessary. Frequency varies by length of service
Check the rotor speed and calibrate it if necessary X
Inspect the rotor for wear, corrosion, and damage X
Replace the rotor if these conditions exist
Inspect the tube holders for wear and damage X
Replace tube holders if they are worn or damaged, or
after they have been in use for two years
Clean the exterior X
Replace the supply and drain tubing X
Replace the tube holder inserts for 10 mm x 75 mm X
tubes
Replace the tube holders every two years

Replace the rotor, every four years (including the tube holders)
47
13 Faults and errors
13.1 Operator faults

Fault Cause Remedy
Incomplete wash • A 24-place rotor is being used, • Check the rotor parameter in the
cycle even though a 12-place rotor system settings.
has been set as the rotor type.
• The filling volume is set too low. • Check the volume (ml) and speed
from the FILL-process in the used
program.
• The injection nozzles are • Clean the injection nozzles.

blocked.
Pellet does not form • The revolutions per minute • Check the spin process from the
on the base of used during the centrifugation run for used program.
tube the agglutination test are too
low.
• The tube holders are left • Check the rotor functions.

hanging in the decantation
position
• Wrong tube type • Check if the used tube is the

same as during the program
validation
No pellet/pellet too • A 12-place rotor is being used, • Check the rotor parameter in
small even though a 24-place rotor the program.
has been set as the rotor type.
• The filling volume is set too high. • Check the saline (ml) parameter
in the program.
• Wrong tube type • Check if the used tube is the

same as during the program-
validation.
The liquid is not • The rotor mechanism is • Check the rotor functions
decanted. defective.
• The revolutions per minute • Check the DECANT-process
during the DECANT-process from the used program.
are too low.
If you detect a variable fill volume over a tolerance of ±15% of the setting, then you must check the fill
port from the rotor and if necessary, you must clean or exchange it.
48
13.2 Software error codes
Error Error Name Description Possible reasons
Code
0 No error Program was successful, no error has
occurred
1 Running Program is still running, so far no error has
been detected (should never be visible in
history)
Motor error
10 Motor Motor could not be started (no speed could • Motor is blocked
startup error be detected) • Motor cable connection
problem
• Motor power supply problem
11 Motor Motor could not accelerate within tolerance • Wrong rotor type selected
acceleration (motor was too slow) • Mechanical friction too big
error
12 Motor Motor could not accelerate within tolerance • Wrong rotor type selected
acceleration (motor was too fast)
error
13 Motor Motor could not hold the desired speed • Wrong rotor type selected
speed error (motor was too slow) Maximum of motor speed limit
too high (4000 rpm can maybe
not been hold)
• Motor speed control does not
work as intended
• Motor speed reading failure
14 Motor Motor could not hold the desired speed • Motor speed control does not
speed error (motor was too fast) work as intended
• Motor speed reading failure
15 Motor brake Motor could not slow down within • Wrong rotor type selected
error tolerance
16 Motor Motor has signalized an error • Motor blocked
internal • Motor over temperature
error • Motor power supply error
17 Motor power The 24 V of the motor supply is not • Lid is detected as open
supply available
Liquid injection system error
20 Pump error Pump was not able to pump the desired • Pipe blocked
amount of liquid • Pump not working
• Flow sensor not working
21 Liquid Not enough liquid available or air is in the • Liquid container empty
container pipe • Air in the pipe
empty • Flow sensor problem
Lid error
30 Lid blocked Open or check button was pressed, but • Lid mechanically blocked
the lid could not be opened.
31 Unlocking Open or “CHECK” button was pressed, but • Motor was still rotating at the
failed the lock could not be unlocked. time the command for
unlocking was received
• Problem with the lock
32 Unexpected Lid was opened without a request. • Emergency unlocking was
unlocking used
49
33 Lid Lid sensor has detected an opening of the • Wrong lid detection of the lid
detection lid, but the lock sensor still signalizes the sensor
failure lock is closed • Wrong lock detection of the
lock sensor
System error
40 Program It was not possible to read the complete
reading program. • Program file is corrupted
error • Not enough dynamic memory
was available
41 Image Not all images could be loaded • An image is missing on the

loading failed flash
• An image on the flash is
corrupted
42 EEPROM- Loading data from EEPROM failed. (reading • EEPROM not initialized (login of
error not possible or checksum for the data is a service user needed)
incorrect) • Communication failure
Miscellaneous
50 Unknown An error has occurred, but the kind of the • Unexpected behavior
error could not be identified
51 Program A running program was interrupted • Power interrupted during a
interrupted running program.
52 Program The program was aborted by the user • User has aborted the program
aborted by
user
53 Imbalance The program was stopped because of an • Rotor was not loaded
imbalance of the rotor symmetrically
• Positioning of the imbalance
sensor not correct
„Screen freeze:
If a screen freeze occurs, not the normal standby mode (push anywhere onto the dark display), perform
a main reset
Perform a MAINS RESET:

• Switch off the mains switch (position "0", fig. 7.1, pos. 3).
• Wait at least 10 seconds and then switch on the mains switch again to position "1".
• Check the history for the last run and report the error code to your local service support
Before you open the lid with the release pin (cha. 4.3) you must check through the window into the lid
that the rotor is at a standstill position
If it is not possible to close the lid => check if there is a small part that has fallen into the lid lock
access hole (fig. 7.5), if so then contact your local service support
50
13.3 Changing the fuse
Switch off the mains switch and remove the power plug from the external power supply from the
mains!
Screw the cap from the fuse holder, fig. 7.1, pos. 6, off by turning it counter-clockwise, 1/8-turn, and pull it out
with the fuse. Exchange the defective fuse and tightly screw it including the cap back into the fuse holder by
turning it in clockwise direction.
Only T10A/125VAC, 6.3 x 32 mm fuses with UL and CSA approval, (order no. UC.E114)
cap, for fuse holder, 6.3 x 32 mm, (order no. UC.E104)
F10AA/250VAC, 5.0 x 20 mm fuses with UL and CSA approval, (order no. UC.E118)
cap, for fuse holder, 5.0 x 20 mm, (order no. UC.E116) may be used.
14 Returning the device / parts of it

If the device, some parts of it or its accessories are returned to Hettich AG or the local supplier, to
provide protection for people, the environment and materials, it must be decontaminated and cleaned
before being shipped, a declaration should to be apply to the device, and respectively to the parts.
Before returning the device, a transport securing part must be installed.

Before returning the device or some parts of it via some local suppliers, you should ask for an RMA-
number (Return Authorization Number)
We reserve the right to refuse contaminated devices or accessories.

Costs incurred for cleaning and disinfection are to be charged to the customer.
15 Storage
Before storing the device, it should be decontaminated and cleaned to protect people, the environment
and property. We suggest putting a declaration onto the device with the date, sign and the solution.
The appliance may only be stored under the following conditions:

- in an enclosed, dust-free room conform to the storage environment, refer to the tech. specifications
(cha. 5, tab. 1)
- frost-free
- disconnected from the power supply
- If the storagetime is longer than 12 months, it’s recommended to remove the battery on the
controller-board
51
15.1 Disposal
Before disposal, the device must be decontaminated and cleaned to protect people, the
environment and property. Please also observe all other regulations applicable in this context. We
suggest applying a declaration to the device with the date, sign and the solution.
When you are disposing of the device, the respective statutory rules must be observed.
Pursuant to guideline 2002/96/EC (WEEE), all devices supplied after August 13, 2005 may not be
disposed as part of domestic (household), or industrial waste. The device belongs to group 8 (medical
devices) and is categorized in the business-to-business field. The icon of the crossed-out trash can
show that the device may not be disposed as part of domestic waste. The waste disposal guidelines
of the individual EC countries might vary. Contact your supplier or the local department for treatment
of waste. There is a lithium battery in the main electronic-board of the device. Remove it and dispose
of it in accordance with the regulations in your country.
Note for Germany:

The device may not be left at public or communal recycling or collection points. If necessary, contact
your supplier or the local department for treatment of waste.
52
16 Appendix
16.1 Rotors and accessories

1017-A (for 1008-00 & -03)
E2197
SM1012-A (for 1008-00S)
Decant Rotor 12-Places
Adapter
1019 1)
Tubes
45°
Capacity: ml 3 5
Dimensions /  x L mm 10 x 75 12 x 75
Number p. rotor 12 12
RPM
Speed: 3500 2)
(U/min)
RZB / RCF: 1438
Radius: mm 105
1)
1019 = Set with 12 pieces
2)
max. speed 3500 rpm / 1438RCF => recheck with the supplier / distributor / manufacturer of the tubes
The rotor for the device type 1008-00S has the article number SM1012-A (without adapter)
All tests carried out by Hettich AG were run with the following tubes:
Glas 10,5x75mm Plant Andeville, Andeville France, und 12x75mm Medion Grifols Diagnostic AG
Düdingen, Switzerland
53
1018-A (for 1008-00 & -03)
E2197
SM1024-A (for 1008-00S)
Dekantierrotor 24-fach /
Decant Rotor 24-Places
Adapter
1019 1)
Tubes
45°
Capacity: ml 3 5
Dimensions  x L: mm 10 x 75 12 x 75
Number p. rotor: 24 24
RPM
Speed: 3500 2)
(U/min)
RZB / RCF: 1438
Radius: mm 105
1)
1019 = Set with 12 pieces
2)
max. speed 3500rpm / 1438RCF => recheck with the supplier / distributor / manufacturer of the tubes
The rotor for the device type 1008-00S has the article number SM1012-A (without adapter)
All tests carried out by Hettich AG were run with the following tubes:
Glas 10,5x75mm Plant Andeville, Andeville France, und 12x75mm Medion Grifols Diagnostic AG
Düdingen, Switzerland
54
16.2 Spare parts
The following quantities are based on a recommendation from the manufacturer.
p/n Description > 5 units > 25 units

E4259 plug, waste, for waste tube X
E4261 plug, Input 1, for saline tube X
E4260 Push-in plug, for emergency-release hole X
E4258 weight for suction tube, INOX X
E4394 elbow nozzle, for drain-hose X
E4373 fill-hose, inlet 1, complete X1
E4374 waste-hose, drain-outlet, with connector X1
E4375 internal tube-set for periodic maintenance X2
E2287-01 emergency-release pin
1 = must be replaced after loan or demo.
2 = Should be replaced after loan or demo.
55
16.3 Document history
rev. supersession Revision description created by created Approved Checked
date by on
1.0 01 - 06 Template, Contents, desc. of preloaded 23.05.2017 MK/DK DF 23.05.2017
programs
1.1 1.0 Correction p/n from accessories, 24.05.2017 MK/DK DF 24.05.2017
implementation of Document History
1.2 1.1 Edit chapter 12, 13, new CE-declaration 04.06.2017 DK DF 04.06.2017
and correction of typing errors
1.3 1.2 Edit chapter 12, new header 07.06.2017 DK DF 07.06.2017
1.4 1.3 Editing formatting and adding the actual 04.09.2017 DK DF 04.09.2017
declaration of conformity
1.5 1.4 Editing of writing and orthographic errors 30.11.2017 DK DF 30.11.2017
1.6 1.5 Editing the address from the 01.12.2017 DK DF 01.12.2017
manufacturer
1.7 1.6 Editing the LOOP-process 01.12.2017 DK DF 01.12.2017
1.8 1.7 Editing of orthographic errors, 22.01.2018 DK DF 22.01.2018
preinstalled programs, notes on safety,
use according to the specifications and
unpacking the centrifuge
1.9 1.8 Description from the preinstalled 16.08.2018 DK DF 16.08.2018
programs, DECANT max value, error 15
2.0 1.9 tech. data (Noise), chapter password 08.01.2019 DK DF 08.01.2019
protection inserted, CE declaration
renewed
2.1 2.0 Edit chapter 2. Paragraph two, 2.1 11.03.2019 DK DF 11.03.2019
software-version, edit chapter 8.1
overview, edit chapter 8.5.2 language,
date and time settings, edit chapter 9.3.3
to 9.3.9 acceleration and braking
presetting, edit chapter 9.4.5 SPIN-
process
2.2 2.1 Add. of the type 1008-00S, Chap. 2 best 07.11.2019 DK DF 02.12.2019
use, Chap. 5 tech. data, Chap. 6.3
Article number and added pictures, ,
Chap. 7.1.1 added, Chap. 9.3, 9.3.10 &
9.3.11 Program and Rotor added for
device 1008-00S, Document history
adapted
2.3 2.2 Cha. 12.5 and 12.1 fixed typing errors, 02.12.2019 DK DF 02.12.2019
revision of the document history
2.4 2.3 adjusted footer, Date p. 2, Cha. 3 typing
errors fixed, line inserted in chap. 7.2
(orthography), access rights corrected in
Chap. 8.2 and 8.5.2, translation errors
corrected in Chap. 8.3, 8.5 and 8.6.2,
font adapted to CI in Chap. 8.6.1 and the
following chapter relocated to the next
page, numbers implemented in pictures
for better understanding in chap. 9.3,
translation error corrected in chap. 9.4.5
and moved to the following page, added
to the article number table and the
reduction note expanded for better
comprehensibility
56
2.5 2.4 Revision status corrected in footer, typing 09.06.2020 LH
error fixed (all chapters), layout adapted
(entire document), all images and tables
inserted in EN and updated according to
the latest software 421, image captions
and descriptions, image references
adjusted (entire document) chap. 5
Technical data, sound pressure level
changed from 49 to 62dB, chap. 16.2
inserted (from service manual), Fig.7.6
(rotor) inserted, chap. 8.1 Overview menu
navigation new picture inserted in DE,
chap. 8.6.3 Lid option explained and
extra picture inserted, 9.4.6 DECANT
new wording, 10.2 Calibration changed
from monthly to weekly, sentence
positions and spellings changed (all
chapters) Chap. 15 Remove storage
battery inserted, chap. 16.1 Added
information regarding glass tubes,
removed operator-manual from list in
Cha. 6.3
57

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Operating Instructions

Cell Washer Centrifuge Hettich Rotolavit II and Rotolavit II-S

phone +41 (0)44 786 80 20

Name und Adresse des Herstellers Hettich AG, Seestrasse 204a,

Rotolavit II, Rotolavit II-S

gefertigt in der Schweiz / manufactured in Switzerland / fabriqué en Suisse / prodotto in Svizzera /

Angewandte gemeinsame technischen Spezifikationen, harmonisierte EN 61010-1

Especificações técnicas comuns aplicadas, normas harmonizadas,

Baech, 30. September 2019 Doris Friedlos Geschäftsleiterin / CEO /

1.1 Explanation of the terms

Caution is used for information that is important for avoiding damage.

1.2 Explanation of signs

Symbol on the device:

Symbol in this document:

Symbol in this document:

Symbol on the device and in this document:

Symbol on the device and in this document:

Symbol in this document:

Symbol in this document:

Symbol in this document:

The following device types are available for this device:

Rotolavit II, Type 1008-00 and 1008-03

Rotolavit II-S, Type 1008-00S

2.2 Storage and forwarding the operator-manual

• is responsible for the use of the password-protection, user-settings (cha.8.6.2).

2.4 Requirements of the operating personnel

2.5 Changes and alterations

When the centrifuge is running, according to EN / IEC 61010-2-020, no persons, dangerous

The centrifuge may not be operated in explosion-endangered areas.

The centrifuge should not be used with:

Repairs must only be carried out by personnel authorised to do so by the manufacturer.

The following safety regulations apply:

You can find on correcting malfunctions in chapter 13.

4.1 Remaining risks

4.2 Switching off the device in an emergency

4.3 Emergency release

For emergency release disconnect the centrifuge from the mains.

• Switch off the mains switch (switch position "0").

Modell Rotolavit II Rotolavit II-S

Optional car-battery DC- no 11–30 VDC no

Humidity 20 %rF to 80 %rF / nicht kondensierend

Storage temperature 5 °C to 50 °C / max. 60%rF

According to the laboratory instrument standards EN / IEC 61010-2-020 an emergency switch to

6.1 Storage after delivery

6.2 Installation after storage

6.4 Disposing of packaging material

* Refer to the technical specifications comparing to

9 Emergency release hole

E4394, angle piece E4373, fill-hose,

hex L-Key E4258, weight for

E4374, drain hose, complete

E4259, plug, for waste tube

E4251 / E4502, power-supply

Fig. 7.2.5 Fig. 7.2.6

Lay the power cable so that

Clean and disinfect the device before first use.

marking for positioning the rotor

7.5 Install and remove the rotor

Rotor installation procedure:

Rotor removal procedure: